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Guidelines on neonatal resuscitation recommend 90 chest compressions (CC) and 30 manual inflations (3:1) per minute in newborns. The study aimed to determine if CC s during sustained inflations (SI) improves recovery of asphyxiated newborns compared to coordinated 3:1 resuscitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SI+CC | Experimental | Chest compression will be superimposed by sustained inflations during CPR: "CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC. |
|
| 3:1 CPR | Active Comparator | CPR using 3:1 C:V ratio: "3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC+SI | Procedure | Chest compression will be superimposed by sustained inflation during CPR |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time Needed to Achieve Return of Spontaneous Circulation | We aim to reduce time needed to achieve Return of Spontaneous Circulation. This should be achieved by the experimental chest compression technique | within the first 10 minutes after birth |
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Inclusion Criteria:
Newborn infants with asystole Newborn infants with bradycardia
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Georg Schmolzer | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Alexandra Hospital | Edmonton | Alberta | T5H 3V9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28988159 | Derived | Schmolzer GM, O Reilly M, Fray C, van Os S, Cheung PY. Chest compression during sustained inflation versus 3:1 chest compression:ventilation ratio during neonatal cardiopulmonary resuscitation: a randomised feasibility trial. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F455-F460. doi: 10.1136/archdischild-2017-313037. Epub 2017 Oct 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SI+CC | Chest compression will be superimposed by sustained inflations during CPR: "CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC. CC+SI: Chest compression will be superimposed by sustained inflation during CPR |
| FG001 | 3:1 CPR | CPR using 3:1 C:V ratio: "3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC. 3:1 CPR: CPR using 3:1 ratio (control group) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SI+CC | Chest compression will be superimposed by sustained inflations during CPR: "CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC. CC+SI: Chest compression will be superimposed by sustained inflation during CPR |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time Needed to Achieve Return of Spontaneous Circulation | We aim to reduce time needed to achieve Return of Spontaneous Circulation. This should be achieved by the experimental chest compression technique | Posted | Mean | Standard Deviation | seconds | within the first 10 minutes after birth |
|
within 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SI+CC | Chest compression will be superimposed by sustained inflations during CPR: "CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC. CC+SI: Chest compression will be superimposed by sustained inflation during CPR |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Air leak | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Georg Schmölzer | University of Alberta | 7807354647 | georg.schmoelzer@me.com |
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| ID | Term |
|---|---|
| D016887 | Cardiopulmonary Resuscitation |
| ID | Term |
|---|---|
| D012151 | Resuscitation |
| D004638 | Emergency Treatment |
| D013812 | Therapeutics |
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| 3:1 CPR |
| Procedure |
CPR using 3:1 ratio (control group) |
|
| BG001 | 3:1 CPR | CPR using 3:1 C:V ratio: "3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC. 3:1 CPR: CPR using 3:1 ratio (control group) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 3:1 CPR | CPR using 3:1 C:V ratio: "3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC. 3:1 CPR: CPR using 3:1 ratio (control group) |
|
|
|
| 2 |
| 5 |
| 1 |
| 5 |
| 0 |
| 5 |
| EG001 | 3:1 CPR | CPR using 3:1 C:V ratio: "3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC. 3:1 CPR: CPR using 3:1 ratio (control group) | 0 | 4 | 4 | 4 | 0 | 4 |
| Intraventricular haemorrhage all grades | Nervous system disorders | Systematic Assessment |
|
| Intraventricular haemorrhage grade >3 | Nervous system disorders | Systematic Assessment |
|
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